AP reports the interim access policy would have FDA hold off on enforcement against pharmacies, despite agency scientists saying the peptides lack safety data.
Recap by typeshit. Full story at Click2Houston.
Even genuine pens with foreign prescriptions are seized. Lawmakers and a regulatory official now want a review, as Mounjaro costs over three times more in Korea than Japan.
Law360 reports the European patent court could limit the use of divisional patents in a fight involving Novo Nordisk and Ozempic.
Novo had asked the court to halt Lilly advertising it objected to. The judge ruled against the request on October 26, Reuters reports.
The think tank argues regulated compounding beats 'research use only' sellers, noting an FDA panel voted to add six peptides despite staff advising against all seven.
The phase 3 trial compared Lilly's pill against insulin glargine in adults with type 2 diabetes at higher cardiovascular risk. Full results are in The Lancet.
Two people familiar with the plan tell AP it would let pharmacies compound popular peptides like BPC-157 without FDA enforcement, despite agency scientists' safety concerns.
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